Downstream processing for biotherapeutics covers an increasingly wide variety of products such as recombinant proteins, vaccines, monoclonal antibodies, and viral vectors for cell and gene therapies.
The IDBS Bioprocess Solution helps in each of these processes. Built-in workflows record process parameters, as well as details relating to equipment and material used, and instrument-generated data. In addition, our solution provides automatic calculations and an easy and clear way to view results, including full sample tracking. On top of that, our solution enables full Inventory and Request management; our workflows provide the flexibility needed for early development of a biotherapeutic as well as the comprehensive documentation and reporting functionality needed for later development.
Downstream workflows include:
In the past, biopharma organizations were run in a department-centric manner for organizational reasons. However, implementing this approach has led to the creation of data silos. Managing data across studies and departments can get tricky when the data is stored in disparate locations on premise and on file.
The key is to increase traceability (both experimental data and materials), transparency and compliance, to encourage communication between departments. This is particularly relevant to downstream and analytical scientists, who must exchange information throughout the procedures involved for in-process control and product quality assessments.
To understand the biopharma value chain, teams preparing buffers and reagents, upstream development, analytical development, QA and other departments working towards the development of a new therapeutic, need to work together – connected on a single platform and sharing data to streamline processes and propel productivity. Our solution’s single execution platform not only facilitates collaboration, it also encourages teamwork. With the IDBS Bioprocess Solution, visualizing trends such as product stability and integrity across unit operations suddenly not only becomes possible, but easy.
Developing a new therapeutic product involves many teams working in partnership, including both internal and external departments. Each level of the process has its own procedures and approaches to handle the data generated – these can be anything from paper and Excel to electronic notebooks on a cloud-based platform. But consistency is important to get measurable positive results that impact the business.
Without consistency, identifying issues and reacting upon on them in time becomes difficult, compiling reports requires so much time that the data and information reported upon is unlikely to be the most recent or accurate, putting critical decision-making at risk. To shorten time to market, workflows must be streamlined, items such as samples, equipment and materials managed in a efficient manner, and the reporting times cut, all while observing good laboratory practice (GLP) where necessary. This platform approach also helps improve data integrity and ensures scientists stick to Standard Operating Procedures (SOPs) in the laboratory.
If you’re looking to discover more about how The IDBS Bioprocess Solution can improve your experimental data management and enhance biologics product quality in your downstream processes, please get in touch with our team of experts here, or click ‘Contact Us’ below.